Functional decline in older breast cancer survivors treated with and without chemotherapy and non-cancer controls: results from the Hurria Older PatiEnts (HOPE) prospective study.

PURPOSE: This study aimed to assess whether physical functional decline in older women with early-stage breast cancer is driven by cancer, chemotherapy, or a combination of both. METHODS: We prospectively sampled three groups of women aged ≥ 65: 444 with early-stage breast cancer receiving chemotherapy (BC Chemo), 98 with early-stage breast cancer not receiving chemotherapy (BC Control), and 100 non-cancer controls (NC Control). Physical function was assessed at two timepoints (T1 [baseline] and T2 [3, 4, or 6 months]) using the Physical Functioning Subscale (PF-10) of the RAND 36-item Short Form. The primary endpoint was the change in PF-10 scores from T1 to T2, analyzed continuously and dichotomously (Yes/No, with "yes" indicating a PF-10 decline > 10 points, i.e., a substantial and clinically meaningful difference). RESULTS: Baseline PF-10 scores were similar across all groups. The BC Chemo group experienced a significant decline at T2, with a median change in PF-10 of -5 (interquartile range [IQR], -20, 0), while BC Control and NC Control groups showed a median change of 0 (IQR, -5, 5; p < 0.001). Over 30% of BC Chemo participants had a substantial decline in PF-10 vs. 8% in the BC Control and 5% in the NC Control groups (p < 0.001). CONCLUSION: In this cohort of older adults with early-stage breast cancer, the combination of breast cancer and chemotherapy contributes to accelerated functional decline. Our findings reinforce the need to develop interventions aimed at preserving physical function, particularly during and after chemotherapy. IMPLICATIONS FOR CANCER SURVIVORS: The high prevalence of accelerated functional decline in older women undergoing breast cancer chemotherapy underscores the urgency to develop interventions aimed at preserving physical function and improving health outcomes. CLINICAL TRIAL: NCT01472094, Hurria Older PatiEnts (HOPE) with Breast Cancer Study.

Primary Treatment Modification and Treatment Tolerability Among Older Chemotherapy Recipients With Advanced Cancer.

Importance: Older adults with advanced cancer are less likely to tolerate treatment with cytotoxic chemotherapy compared with younger patients due to their aging-related conditions. Hence, oncologists sometimes opt to employ primary treatment modifications (deviation from standard of care) during the first cycle of chemotherapy. Objective: To examine the association between primary treatment modification and treatment tolerability in older adults with advanced cancer who were starting new palliative chemotherapy regimens. Design, Setting, and Participants: This cohort study was a secondary analysis of the GAP70+ (Geriatric Assessment Intervention for Reducing Toxicity in Older Patients with Advanced Cancer) trial, which was conducted between July 2014 and March 2019. The GAP70+ trial included patients aged 70 years or older who had advanced (ie, incurable) cancer, had 1 or more geriatric assessment domain impairments, and planned to start a new palliative chemotherapy regimen. Data analysis was conducted in November 2022. Exposures: Receipt of standard-of-care chemotherapy regimens vs primary treatment modification defined as any change from National Comprehensive Cancer Network guidelines or published clinical trials (eg, primary dose reduction, schedule change). Main Outcomes and Measures: Tolerability outcomes were assessed within 3 months of treatment. These outcomes included the following: (1) any grade 3 to 5 toxic effect, according to the National Cancer Institute Common Terminology Criteria for Adverse Events; (2) patient-reported functional decline, defined as the development of worse dependency in activities of daily living using scale scores; and (3) a composite adverse outcome (an end point that combined toxic effects, functional decline, and 6-month overall survival). Multivariable cluster-weighted generalized estimating equation models examined the association between primary treatment modification and outcomes adjusting for covariates. Results: This study included 609 patients with a mean (SD) age of 77.2 (5.2) years; more than half (333 [54.7%]) were men. Race and ethnicity was available for 607 patients: 39 (6.4%) were Black, 539 (88.5%) were non-Hispanic White, and 29 (4.8%) were of other race or ethnicity. Nearly half (281 [46.1%]) received a primary modified treatment regimen. The most common cancer types were gastrointestinal cancer (228 [37.4%]) and lung cancer (174 [28.6%]). In multivariable analysis, primary treatment modification was associated with a reduced risk of grade 3 to 5 toxic effects (relative risk [RR], 0.85 [95% CI, 0.77-0.94]) and functional decline (RR, 0.80 [95% CI, 0.67-0.95]). Patients who received primary treatment modification had 32.0% lower odds of having a worse composite adverse outcome (odds ratio, 0.68 [95% CI, 0.48-0.97]). Conclusions and Relevance: In this cohort study, primary treatment modification was associated with improved tolerability of chemotherapeutic regimens among older adults with advanced cancer and aging-related conditions. These findings may help optimize cancer treatment dosing in older adults with advanced cancer and aging-related conditions.

Researcher Experience and Comfort With Telemedicine and Remote Patient Monitoring in Cancer Treatment Trials.

BACKGROUND: Since the onset of COVID-19, oncology practices across the US have integrated telemedicine (TM) and remote patient monitoring (RPM) into routine care and clinical trials. The extent of provider experience and comfort with TM/RPM in treatment trials, however, is unknown. We surveyed oncology researchers to assess experience and comfort with TM/RPM. METHODS: Between April 10 and June 1, 2022, we distributed email surveys to US-based members of the American Society of Clinical Oncology (ASCO) whose member records indicated interest or specialization in clinical research. We collected respondent demographic data, clinical trial experience, workplace characteristics, and comfort and experience with TM/RPM use across trial components in phase I and phase II/III trials. TM/RPM was defined as clinical trial-related healthcare and monitoring for patients geographically separated from trial site. RESULTS: There were 141 surveys analyzed (5.1% response rate). Ninety percent of respondents had been Principal Investigators, 98% practiced in a norural site. Most respondents had enrolled patients in phase I (82%) and phase II/III trials (99%). Across all phases and trial components, there was a higher frequency of researcher comfort compared to experience. Regarding remote care in treatment trials, 75% reported using TM, RPM, or both. Among these individuals, 62% had never provided remote care to trial patients before the pandemic. CONCLUSION: COVID-19 spurred the rise of TM/RPM in cancer treatment trials, and some TM/RPM use continues in this context. Among oncology researchers, higher levels of comfort compared with real-world experience with TM/RPM reveal opportunities for expanding TM/RPM policies and guidelines in oncology research.

Falls prechemotherapy and toxicity-related hospitalization during adjuvant chemotherapy for breast cancer in older women: Results from the prospective multicenter HOPE trial.

BACKGROUND: Older women with breast cancer frequently experience toxicity-related hospitalizations during adjuvant chemotherapy. Although the geriatric assessment can identify those at risk, its use in clinic remains limited. One simple, low-cost marker of vulnerability in older persons is fall history. Here, the authors examined whether falls prechemotherapy can identify older women at risk for toxicity-related hospitalization during adjuvant chemotherapy for breast cancer. METHODS: In a prospective study of women >65 years old with stage I-III breast cancer treated with adjuvant chemotherapy, the authors assessed baseline falls in the past 6 months as a categorical variable: no fall, one fall, and more than one fall. The primary end point was incident hospitalization during chemotherapy attributable to toxicity. Multivariable logistic regression was used to examine the association between falls and toxicity-related hospitalization, adjusting for sociodemographic, disease, and geriatric covariates. RESULTS: Of the 497 participants, 60 (12.1%) reported falling before chemotherapy, and 114 (22.9%) had one or more toxicity-related hospitalizations. After adjusting for sociodemographic, disease, and geriatric characteristics, women who fell more than once within 6 months before chemotherapy had greater odds of being hospitalized from toxicity during chemotherapy compared to women who did not fall (50.0% vs. 20.8% experienced toxicity-related hospitalization, odds ratio, 4.38; 95% confidence interval, 1.66-11.54, p = .003). CONCLUSIONS: In this cohort of older women with early breast cancer, women who experienced more than one fall before chemotherapy had an over 4-fold increased risk of toxicity-related hospitalization during chemotherapy, independent of sociodemographic, disease, and geriatric factors.

Cancer survivorship challenges of rural older adults: a qualitative study.

BACKGROUND: Although research has advanced the field of oncologic geriatrics with survivors to assess their cancer-related needs and devise patient-centered interventions, most of that research has excluded rural populations. This study aimed to understand the survivorship challenges and recommendations in the perspective of rural older adults. METHODS: This was a qualitative study that explored the survivorship challenges and recommendations of rural older adults who have completed curative intent chemotherapy for a solid tumor malignancy in the 12 months prior to enrollment in the present study. RESULTS: Twenty-seven older adult survivors from rural areas completed open-ended semi-structured interviews. The mean age was 73.4 (SD = 5.0). Most participants were non-Hispanic White (96.3%), female (59.3%), married (63.0%), and had up to a high school education (51.9%). Rural older survivors reported a general lack of awareness of survivorship care plans, communication challenges with healthcare team, transportation challenges, financial toxicity, psychological challenges, and diet and physical challenges. Rural older survivors recommend the provision of nutritional advice referral to exercise programs, and social support groups and for their healthcare providers to discuss their survivorship plan with them. CONCLUSIONS: Although study participants reported similar survivorship challenges as urban older adult survivors, additional challenges reported regarding transportation and consideration of farm animals have not been previously reported. Heightened awareness of the survivorship needs of rural older adults may result in better survivorship care for this population.

Information Technology and Telemedicine Services in Community Oncology Practices.

PURPOSE: We described information technology support and use of telemedicine for cancer care and research purposes at community oncology practices within the National Cancer Institute Community Oncology Research Program (NCORP). METHODS: We used data from the NCORP 2017 and 2022 Landscape Assessments. Separate logistic regression models were used to assess factors associated with the use of telemedicine for delivery of cancer care in 2017 and for research purposes in 2022 (cancer care delivery not assessed in 2022). RESULTS: Information was available from 210 and 259 practice groups excluding pediatric-only groups in 2017 and 2022, respectively. In 2017, 30% of practice groups used telemedicine for delivery of cancer care; half of these (15% overall) could use telemedicine for research purposes. In 2022, telemedicine was used for research purposes in 73% of practice groups. In multivariable models, self-identifying as a safety-net hospital was associated with a lower odd of telemedicine use for delivery of cancer care (adjusted odds ratio [AOR], 0.39; 95% CI, 0.17 to 0.93), whereas affiliation with a designated critical access hospital was associated with a higher odd of telemedicine use for delivery of cancer care (AOR, 2.29; 95% CI, 1.10 to 4.76). Having a general survivorship clinic (AOR, 1.92; 95% CI, 1.04 to 3.54) and number of oncology providers (increase per 10 providers; AOR, 1.32; 95% CI, 1.05 to 1.65) were associated with telemedicine use for research purposes. CONCLUSION: Almost one third of NCORP practice groups used telemedicine for cancer care delivery in 2017. In 2022, there is high capacity among NCORP practices (almost three-quarters) to use telemedicine for research purposes, especially among practices with a general survivorship clinic and a greater provider number.

Associations of interleukin-6 with functional trajectories in older adults with cancer: Findings from the Health, Aging, and Body Composition Study.

BACKGROUND: Elevated markers of inflammation, such as interleukin-6 (IL-6), are associated with aging, cancer, and functional decline. We assessed the association of pre-diagnosis IL-6 levels with post-diagnosis functional trajectories among older adults with cancer. Black and White participants experience different social structures, therefore we sought to understand whether these associations differ between Black and White participants. METHODS: We conducted secondary analysis of the Health Aging, Body, and Composition (ABC) prospective longitudinal cohort study. Participants were recruited from 4/1997 to 6/1998. We included 179 participants with a new cancer diagnosis and IL-6 level measured within 2 years before diagnosis. Primary endpoint was functional measures (self-reported ability to walk 1/4, 20-meter gait speed). Nonparametric longitudinal models were used to cluster the trajectories; multinomial and logistic regressions to model associations. FINDINGS: Mean age was 74 (SD 2.9); 36 % identified as Black. For self-reported functional status, we identified 3 clusters: high stable, decline, low stable. For gait speed, we identified 2 clusters: resilient, decline. The relationship between cluster trajectory and IL-6 was different between Black and White participants (p for interaction<0.05). For gait speed, among White participants, a greater log IL-6 level was associated with greater odds of being in the decline vs. resilient cluster [Adjusted Odds Ratio (AOR): 4.31, 95 % CI: 1.43, 17.46]. Among Black participants, a greater log IL-6 levels were associated with lower odds of being in the decline vs. resilient cluster (AOR: 0.49, 95 % CI: 0.10, 2.08). Directionality was similar for self-reported ability to walk » mile (high stable vs. low stable). Among White participants, a higher log IL-6 level was associated numerically with greater odds of being in the low stable vs. high stable cluster (AOR: 1.99, 95 % CI: 0.82, 4.85). Among Black participants, a higher log IL-6 level was associated numerically with lower odds of being in the low stable cluster vs. high stable cluster (AOR: 0.78, 95 % CI: 0.30, 2.00). INTERPRETATION: The association between IL-6 levels and functional trajectories of older adults differed by race. Future analyses exploring stressors faces by other minoritized racial backgrounds are needed to determine the association between IL-6 and functional trajectories. PANEL: RESEARCH IN CONTEXT: Evidence before this study: Previous research has shown that aging is the greatest risk factor for cancer and older adults with cancer experience a higher burden of comorbidities, increasing their risk of functional decline. Race has also been shown to be associated with increased risk for functional decline. Black individuals are exposed to more chronic negative social determinants, compared to White individuals. Previous work has shown that chronic exposure to negative social determinants leads to elevated levels of inflammatory markers, such as IL-6, but studies investigating the relationship between inflammatory markers and functional decline are limited. Added value of this study: Authors of this study sought to understand the association between pre-diagnosis IL-6 levels and functional trajectories post-diagnosis in older adults with cancer, and whether these associations differed between Black and White participants with cancer. Authors decided to utilize the data from the Health, Aging and Body Composition (Health ABC) Study. The Health ACB study was a prospective longitudinal cohort study that has a high representation of Black older adults and collected inflammatory cytokines and physical function data over time. Implications of all available evidence: This work adds to the literature by providing an opportunity to study the difference in the relationships between IL-6 levels and functional trajectories between older Black and White participants with cancer. Identifying factors associated with functional decline and its trajectories may inform treatment decision making and guide development of supportive care interventions to prevent functional decline. Additionally, given the disparities in clinical outcomes for Black individuals, a better understanding of the difference in functional decline based on race will allow more equitable care to be distributed.

External Validation of Risk Factors for Unplanned Hospitalization in Older Adults With Advanced Cancer Receiving Chemotherapy.

BACKGROUND: Older adults (age ≥65 years) receiving chemotherapy are at risk for hospitalization. Predictors of unplanned hospitalization among older adults receiving chemotherapy for cancer were recently published using data from a study conducted by the Cancer and Aging Research Group (CARG). Our study aimed to externally validate these predictors in an independent cohort including older adults with advanced cancer receiving chemotherapy. METHODS: This validation cohort included patients (n=369) from the GAP70+ trial usual care arm. Enrolled patients were aged ≥70 years with incurable cancer and were starting a new line of chemotherapy. Previously identified risk factors proposed by the CARG study were ≥3 comorbidities, albumin level <3.5 g/dL, creatinine clearance <60 mL/min, gastrointestinal cancer, ≥5 medications, requiring assistance with activities of daily activities (ADLs), and having someone available to take them to the doctor (ie, presence of social support). The primary outcome was unplanned hospitalization within 3 months of treatment initiation. Multivariable logistic regression was applied including the 7 identified risk factors. Discriminative ability of the fitted model was performed by calculating the area under the receiver operating characteristic (AUC) curve. RESULTS: Mean age of the cohort was 77 years, 45% of patients were women, and 29% experienced unplanned hospitalization within the first 3 months of treatment. The proportions of hospitalized patients with 0-3, 4-5, and 6-7 identified risk factors were 24%, 28%, and 47%, respectively (P=.04). Impaired ADLs (odds ratio, 1.76; 95% CI, 1.04-2.99) and albumin level <3.5 g/dL (odds ratio, 2.23; 95% CI, 1.37-3.62) were significantly associated with increased odds of unplanned hospitalization. The AUC of the model, including the 7 identified risk factors, was 0.65 (95% CI, 0.59-0.71). CONCLUSIONS: The presence of a higher number of risk factors was associated with increased odds of unplanned hospitalization. This association was largely driven by impairment in ADLs and low albumin level. Validated predictors of unplanned hospitalization can help with counseling and shared decision-making with patients and their caregivers. CLINICALTRIALS: gov identifier: NCT02054741.

Mental health outcomes and correlates in cancer patients entering survivorship after curative treatment.

OBJECTIVE: Cancer survivors face numerous physical and mental health challenges after treatment completion. However, few studies have examined mental health in cancer survivors who received curative treatment during the transition out of active treatment and into survivorship. The current study describes the mental health outcomes and their correlates in cancer survivors treated with curative intent during the first year of survivorship. METHODS: A total of 120 cancer survivors of any cancer type completed a survey that assessed depression, anxiety, death ideation, alcohol and substance use, and demographic characteristics. Data regarding cancer type and treatment were extracted from the medical record. RESULTS: Approximately 15% of the sample reported depressive symptoms. Fifteen percent also reported anxiety symptoms in the past two weeks. Ten percent of the sample reported experiencing death ideation since their treatment ended and 7.5% reported death ideation in the past two weeks. Younger age, previous psychiatric diagnosis, and current substance use were associated with depressive symptoms, anxiety symptoms, and death ideation. CONCLUSION: Cancer survivors entering survivorship after curative treatment experience an increased rate of depressive symptoms, anxiety symptoms, and death ideation. Younger cancer survivors and those with previous psychiatric diagnoses or substance use may be at particular risk for mental health problems during the first year of survivorship. Future research within both oncology and primary care should further examine modifiable risk factors for depression, anxiety, and death ideation in cancer survivors at the transition into survivorship after curative treatment to improve survivorship care.

The role of self-perceived age in older adults considering adjuvant chemotherapy.

INTRODUCTION: Aging-related concerns can increase the risk of treatment toxicities among older adults considering adjuvant chemotherapy. We previously demonstrated that older adults with cancer who reported feeling older than their chronological age (i.e., self-perceived age) were more likely to have aging-related concerns identified during a geriatric assessment. We explored how decisions about adjuvant chemotherapy vary with or are related to older adults' self-perceived age. MATERIALS AND METHODS: We conducted a secondary analysis of a multi-phased feasibility pilot using semi-structured interviews that were conducted to explore the patient decision-making process for adjuvant chemotherapy. Interviews incorporated questions about chronological and perceived age as factors for decision-making. Patient eligibility for the study included (1) age ≥ 70 years and older, (2) a diagnosis of breast, colon, or lung cancer and considering adjuvant chemotherapy, and (3) able to read size 18 font in English. Interview data were analyzed using constant comparative method. RESULTS: Twenty-one patients were enrolled. The mean chronological age was 78 years (range 71-91). The average perceived age of patients was 57 years (range 21-80). Eleven patients chose to receive treatment while ten patients did not. Aging-related themes illustrated that self-perceived age plays an important role when patients make decisions about adjuvant chemotherapy. More specifically, patients who reported their self-perceived age as younger than their chronological age also reported better perceived health status and chose to receive adjuvant chemotherapy. DISCUSSION: Patients' experiences of aging and self-perceived age may have different implications for decision-making.

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer.

PURPOSE: Providing a geriatric assessment (GA) summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving treatment. This secondary analysis of a national cluster randomized clinical trial (ClinicalTrials.gov identifier: NCT02054741) aims to assess the effects of a GA intervention on symptomatic toxicity measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). METHODS: From 2014 to 2019, the study enrolled patients age ≥ 70 years, with advanced solid tumors or lymphoma and ≥ 1 GA domain impairment, who were initiating a regimen with high prevalence of toxicity. Patients completed PRO-CTCAEs, including the severity of 24 symptoms (11 classified as core symptoms) at enrollment, 4-6 weeks, 3 months, and 6 months. Symptoms were scored as grade ≥ 2 (at least moderate) and grade ≥ 3 (severe/very severe). Symptomatic toxicity was determined by an increase in severity during treatment. A generalized estimating equation model was used to assess the effects of the GA intervention on symptomatic toxicity. RESULTS: Mean age was 77 years (range, 70-96 years), 43% were female, and 88% were White, 59% had GI or lung cancers, and 27% received prior chemotherapy. In 706 patients who provided PRO-CTCAEs at baseline, 86.1% reported at least one moderate symptom and 49.7% reported severe/very severe symptoms at regimen initiation. In 623 patients with follow-up PRO-CTCAE data, compared with usual care, fewer patients in the GA intervention arm reported grade ≥ 2 symptomatic toxicity (overall: 88.9% v 94.8%, P = .035; core symptoms: 83.4% v 91.7%, P = .001). The results for grade ≥ 3 toxicity were comparable but not significant (P > .05). CONCLUSION: In the presence of a high baseline symptom burden, a GA intervention for older patients with advanced cancer reduces patient-reported symptomatic toxicity.

Low-Intensity Adjuvant Chemotherapy for Breast Cancer in Older Women: Results From the Prospective Multicenter HOPE Trial.

PURPOSE: Older women with high-risk early breast cancer (EBC) benefit from adjuvant chemotherapy, but their treatment is frequently complicated by toxic side effects, resulting in dose reductions and delays. This makes it challenging for oncologists to maintain a relative dose intensity (RDI) ≥ 85%, as recommended for optimal curative-intent treatment. Understanding which women are at risk of receiving suboptimal RDI may inform treatment discussions and guide early, targeted supportive care or geriatric comanagement interventions. METHODS: This was a prespecified secondary analysis of the HOPE trial, which enrolled women age ≥ 65 years with EBC initiating neoadjuvant or adjuvant chemotherapy. RDI was calculated as the ratio of delivered to planned chemotherapy dose intensity. The primary outcome was low RDI, defined as RDI < 85%. Multivariable logistic regression with stepwise selection was used to evaluate the association between baseline variables (demographic, clinical, and geriatric assessment) and low RDI. Survival probability was estimated using the Kaplan-Meier method, and the log-rank test was used to compare overall survival. RESULTS: Three hundred twenty-two patients (median age at diagnosis, 70 years; range, 65-86 years) were included. The median follow-up was 4 years. Sixty-six patients (21%) had a low RDI. Age ≥ 76 years (odds ratio [OR], 2.57; 95% CI, 1.12 to 5.91; P = .03), lower performance status (OR, 4.32; 95% CI, 1.98 to 9.42; P < .001), and use of anthracycline-based or cyclophosphamide, methotrexate, and fluorouracil regimens (OR, 3.47; 95% CI, 1.71 to 7.05; P < .001) were associated with low RDI. The 5-year overall survival probability was 0.80 versus 0.91 in patients with RDI < 85 versus ≥ 85%, respectively (log-rank P = .02). CONCLUSION: One in five older patients with EBC treated with standard chemotherapy received low RDI and had inferior survival outcomes. Older patients at risk for low RDI should be identified and targeted upfront before initiating chemotherapy.

Change in four measures of physical function among older adults during lung cancer treatment: A mixed methods cohort study.

INTRODUCTION: Functional outcomes during non-small cell lung cancer (NSCLC) treatment are critically important to older adults. Yet, data on physical function and which measures best capture functional change remain limited. MATERIALS AND METHODS: This multisite, mixed methods cohort study recruited adults ≥65 years with advanced NSCLC starting systemic treatment (i.e., chemotherapy, immunotherapy, and/or targeted therapy) with non-curative intent. Participants underwent serial geriatric assessments prior to starting treatment and at one, two, four, and six months, which included the Karnofsky Performance Scale (KPS, range: 0-100%), instrumental activities of daily living (IADL, range: 0-14), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Physical Functioning subscale (EORTC QLQ-C30 PF, range: 0-100), and Life-Space Assessment (LSA, range: 0-120). For all measures, higher scores represent better functioning. In a qualitative substudy, 20 patients completed semi-structured interviews prior to starting treatment and at two and six months to explore how treatment affected their daily functioning. We created joint displays for each interview participant that integrated their longitudinal KPS, IADL, EORTC QLQ-C30 PF, and LSA scores with patient quotes describing their function. RESULTS: Among 87 patients, median age was 73 years (range 65-96). Mean pretreatment KPS score was 79% (standard deviation [SD] 13), EORTC QLQ-C30 PF was 69 (SD 23), and LSA was 67 (SD 28); median IADL was 13 (interquartile range [IQR] 10-14). At two months after treatment initiation, 70% of patients experienced functional decline on at least one measure, with only 13% of these patients recovering at six months. At two and six months, decline in LSA was the most common (48% and 35%, respectively). Joint displays revealed heterogeneity in how well each quantitative measure of physical function captured the qualitative patient experience. DISCUSSION: Functional decline during NSCLC treatment is common among older adults. LSA is a useful measure to detect subtle functional decline that may be missed by other measures. Given heterogeneity in how well each quantitative measure captures changes in physical function, there is value to including more than one functional measure in geriatric oncology research studies.

Integrating Geriatric Assessment Measures into National Cancer Institute Clinical Trials.

To improve the care of older adults with cancer, the traditional approach to clinical trial design needs to be reconsidered. Older adults are underrepresented in clinical trials with limited or no information on geriatric-specific factors, such as cognition or comorbidities. To address this knowledge gap and increase relevance of therapeutic clinical trial results to the real-life population, integration of aspects relevant to older adults is needed in oncology clinical trials. Geriatric assessment (GA) is a multidimensional tool comprising validated measures assessing specific health domains that are more frequently affected in older adults, including aspects related to physical function, comorbidity, medication use (polypharmacy), cognitive and psychological status, social support, and nutritional status. There are several mechanisms for incorporating either the full GA or specific GA measures into oncology therapeutic clinical trials to contribute to the overarching goal of the trial. Mechanisms include utilizing GA measures to better characterize the trial population, define trial eligibility, allocate treatment receipt within the context of the trial, develop predictive models for treatment outcomes, guide supportive care strategies, personalize care delivery, and assess longitudinal changes in GA domains. The objective of this manuscript is to review how GA measures can contribute to the overall goal of a clinical trial, to provide a framework to guide the selection and integration of GA measures into clinical trial design, and ultimately enable accrual of older adults to clinical trials by facilitating the design of trials tailored to older adults treated in clinical practice.

The Effects of a Mediterranean Diet Intervention on Cancer-Related Fatigue for Patients Undergoing Chemotherapy: A Pilot Randomized Controlled Trial.

Cancer-related fatigue is a common, burdensome symptom of cancer and a side-effect of chemotherapy. While a Mediterranean Diet (MedDiet) promotes energy metabolism and overall health, its effects on cancer-related fatigue remain unknown. In a randomized controlled trial, we evaluated a rigorous MedDiet intervention for feasibility and safety as well as preliminary effects on cancer-related fatigue and metabolism compared to usual care. Participants had stage I−III cancer and at least six weeks of chemotherapy scheduled. After baseline assessments, randomization occurred 2:1, MedDiet:usual care. Measures were collected at baseline, week 4, and week 8 including MedDiet adherence (score 0−14), dietary intake, and blood-based metabolic measures. Mitochondrial respiration from freshly isolated T cells was measured at baseline and four weeks. Participants (n = 33) were 51.0 ± 14.6 years old, 94% were female, and 91% were being treated for breast cancer. The study was feasible, with 100% completing the study and >70% increasing their MedDiet adherence at four and eight weeks compared to baseline. Overall, the MedDiet intervention vs. usual care had a small-moderate effect on change in fatigue at weeks 4 and 8 (ES = 0.31, 0.25, respectively). For those with a baseline MedDiet score <5 (n = 21), the MedDiet intervention had a moderate-large effect of 0.67 and 0.48 at weeks 4 and 8, respectively. The MedDiet did not affect blood-based lipids, though it had a beneficial effect on fructosamine (ES = −0.55). Fatigue was associated with mitochondrial dysfunction including lower basal respiration, maximal respiration, and spare capacity (p < 0.05 for FACIT-F fatigue subscale and BFI, usual fatigue). In conclusion, the MedDiet was feasible and attenuated cancer-related fatigue among patients undergoing chemotherapy, especially those with lower MedDiet scores at baseline.